Pharmaceutical, medical device and biotechnology (sponsor) companies that wish to bring a product to market in the United States must have their product undergo Food and Drug Administration (FDA) reviewed clinical studies. The purpose of these studies includes testing the efficacy and safety of products on human subjects (also, referred to herein as patients or study participants). Since these studies address the medical status and health aspects of the subjects, the Health Insurance Portability and Accountability Act of 1996 (HIPPA) pertains to the use and disclosure of the subjects' personal health information (PHI) and subject privacy. In addition, guidelines laid out by Department of Health and Human Services (HHS) and the FDA Protection of Human Subjects Regulations (45 CFR part 46 or 21 CFR parts 50 and 56, respectively) lay out guidelines to protect such personal health information from inappropriate use or disclosure. Furthermore, HHS issued regulations entitled “Standards for Privacy of Individually Identifiable Health Information,” commonly known as the “Privacy Rule,” broadens the scope of patient related information considered private by defining “individually identifiable health information.”
All information collected concerning an individual subject throughout the course of a clinical study (including even the most basic data points such as name, address and date of birth) can be considered to fall within the purview of PHI and “individually identifiable health information.” Accordingly, it is expected that any and all parties who require access or use of patient information be limited to the minimum amount of information relevant to such a party. For example, the accountant of a clinical study site (investigative site) need not receive access to a patient's name, place of residence, or medical condition in order to reconcile the books of the business.
Clinical studies often provide compensation to study participants for their time, effort and expenses incurred. Typically, this is an expense borne by the sponsor of the study and administered by the study coordinators who interact with the subjects in a trial, and must adhere to the study-specific protocols that govern the study and that detail the structure of patient compensation. Historically, these payments were made via cash or check. Both cash and checks have disadvantages within the clinical study compensation process. Cash provides no reproducible proof of compensation. Checks often take weeks to be issued and require a subject to have a bank account or incur check cashing fees. In addition, it oftentimes proves to be difficult, if not impossible, to provide records to the sponsor or other parties associated with the execution of an ongoing clinical study of the compensation paid to the subjects for the purposes of auditing or reconciliation, without revealing sensitive information which the sponsor should not be exposed to. The present invention addresses this need.